Evaluating the Hexanium TLIF System for treating degenerative disc disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to confirm the safety and efficacy of the Hexanium TLIF system in treating patients with degenerative disc disease. It involves both retrospective and prospective subjects, allowing for the collection of data from patients who have already undergone the procedure as well as those scheduled for it. Participants will be monitored for up to 24 months post-surgery, with assessments focusing on back and leg pain, disability levels, and any adverse effects experienced. Key metrics include Visual Analogue Scores (VAS) and the Oswestry Disability Index (ODI).

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
* Patient of 18 years old or more
* Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

* Infection, local to the operative site
* Signed of local inflammation
* Fever or leukocytosis
* Morbid obesity
* Pregnancy
* Paediatric cases, or patient still having general skeletal growth
* Spondylolisthesis unable to be reduced to Grade I
* Suspected or documented allergy or intolerance to metal
* Any case where the implant components selected for use would be too large or too small to achieve a successful result
* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Prior fusion at the level to be treated
* Any case not needing a bone graft or fusion
* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
* Mental illness
* Any patient unwilling to cooperate with post-operative instructions

Where it's running

• Clinique du dos Terrefort
  Bruges, France Recruiting
• Clinique Saint Charles
  Lyon, France Recruiting
• Hopital privé Clairval
  Marseille, France Recruiting
• CHRU Nancy
  Nancy, France Recruiting
• Polyclinique Majorelle
  Nancy, France Recruiting
• Clinicque Générale Beaulieu
  Geneva, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Noel Graziani, Professor — Hopital Privé Clairval
• Study coordinator: Renaud Duchenes
• Email: r.duchenes@spinevision.com
• Phone: +33 6 86 16 61 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.